MedTech Intelligence Volume 10 Issue 28

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	Volume 10 Issue No. 28

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

Save the Dates! - Medical Device Process Validation: A Virtual Conference - September 17 - 18, 2018

Featured Articles

Soapbox

Horst Giesen, Messe Düsseldorf Digitization and IT Trends Among Key Topics at
MEDICA 2018

By Horst Giesen, Messe Düsseldorf

Digital transformation, artificial intelligence and start-up technologies are some of the topics that will be discussed at the event in November.

Ameing for Asia

Ames Gross, Pacific Bridge Medical 9 Key Questions to Ask Before Registering Your Medical Product in Asia

By Ames Gross, Pacific Bridge Medical

Many considerations should not be overlooked.

Featured Quote

Instead of simply looking at the design and manufacturing done by the OEM, the FDA has identified instances in recent years where the root cause of a patient injury occurred at lower levels of the supply chain, even as low as the raw material-level suppliers.

— Kevin Becker, Spectralytics, Inc.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International One and Done: It Happens!

By Dr. Christopher Joseph Devine,
Devine Guidance International

When it comes to adverse event reporting, the FDA does not grant exemptions.

Soapbox

Peter Rose, Maetrics New MDR: One Year into the
Transition Period

By Peter Rose, Maetrics

After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.

Sponsored Content

Accumold 5 Things Everyone
Needs to Know About Micro Molding

With the pressure on design engineers to deliver smaller, lighter, and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like - What is micro molding? How is it different from standard molding? – are commonly asked by engineers. This whitepaper will explore the answers to these and other pertinent questions.

MedTech M&A: Regulatory & Quality Due Diligence

Save the Dates! - EU MDR Implementation Strategies Workshop - November 27-28, 2018 - Washington DC

Resource Centers

Resource Centers are single topic focused micro-sites within MedTechIntelligence.com that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Audits, Certification & Verification
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M
Medical Recall

Upcoming Events & Webinars

September 17-18, 2018 - Medical Device Process Validation Virtual Conference
Washington, DC

October 22-23, 2018 - Med Tech M&A: Regulatory & Quality Due Diligence
Washington, DC

October 24, 2018 - Medical Technology: Import/Export Workshop
Washington, DC

November 27-28, 2018 - EU MDR Implementation Strategies Workshop
Washington, DC

November 29-30, 2018 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

Q1 2019 - Digital Health Technologies Conference
Silicon Valley, CA

Q1 2019 - Medical Cybersecurity - Remediation of Legacy Medical Devices
Silicon Valley, CA

Q1 2019 - MedTech Innovation Mergers & Acquisitions Workshop
Silicon Valley, CA